Standard: AAMI 8638

CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS — EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS

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Scope:

This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration and hemofiltration.

This International Standard does not apply to:

— hemodialyzers, hemodiafilters or hemofilters;

— plasmafilters;

— hemoperfusion devices;

— vascular access devices;

— blood pumps;

— pressure monitors for the extracorporeal blood circuit;

— air detection devices;

— systems to prepare, maintain or monitor dialysis fluid;

— systems or equipment intended to perform hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration.

NOTE Requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators are specified in ISO 8637.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 8638
Publish Date: 2010-01-01
Page Count: 26
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active
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